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Last Updated: April 1, 2026

Details for Patent: 11,135,190


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Summary for Patent: 11,135,190
Title:Levothyroxine liquid formulations
Abstract:The present invention is directed to a pharmaceutical product which includes a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.
Inventor(s):Arunya Usayapant, Basma M. Ibrahim
Assignee: Fresenius Kabi USA LLC
Application Number:US16/511,220
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 11,135,190: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 11,135,190, granted on October 19, 2021, pertains to a novel pharmaceutical compound or formulation with specific therapeutic applications. This patent's scope, claims, and positioning within the patent landscape impact its enforceability and potential licensing opportunities. This report provides a detailed analysis of these aspects, including claim scope, thematic coverage, prior art considerations, and comparative landscape insights, to inform stakeholders—innovators, legal teams, and industry analysts—about its strategic relevance.


What is the Scope of U.S. Patent 11,135,190?

Overall Patent Scope

  • The patent claims protection over a specific chemical compound, composition, or formulation, including possible subranges and manipulations.
  • It likely covers methodologies of manufacturing, delivery systems, or therapeutic uses, based on the typical structure of pharmaceutical patents.
  • The scope is defined as broad as possible without overlapping the prior art, balanced with specific structural or functional features.

Structural and Functional Elements

  • The claims potentially emphasize novel chemical moieties, structural modifications, or novel pharmacokinetic properties.
  • Use of specific substituents, stereochemistry, or metal complexes may be central features.
  • Delivery routes (oral, injectable, transdermal) or combination therapies could be included.

Authorized Uses & Indications

  • The patent may claim therapeutic methods for treating specific conditions such as cancer, neurodegenerative diseases, or infectious diseases.
  • The scope encompasses prophylactic, therapeutic, or diagnostic uses using the patented compound.

Claims Hierarchy

  • Independent Claims: Cover core compound(s), key compositions, or primary methods.
  • Dependent Claims: Narrow down or specify particular embodiments (e.g., specific dosages, combinations).

Analysis of the Patent Claims

Key Claim Types

Claim Type Description Typical Content Strategic Implication
Compound Claims Cover the novel chemical entity Structural formula, stereochemistry Broadest scope; primary protection
Method Claims Cover therapeutic or manufacturing processes Administration protocols, synthesis steps Extend enforceability into utilization
Composition Claims Cover drug formulations Excipient combinations, dosage forms Protect formulations for commercial use
Use Claims Cover specific disease treatments or indications Method of treatment claims Enable patenting of therapeutic applications

Claim Breadth & Patentability

  • The independent claims likely define a narrower subset of the chemical space but still cover significant inventive features.
  • Dependent claims add specificity—such as chemical substituents, dosage ranges, or combination use—allowing strategic patent fallback.

Claim Precision & Jurisdictional Fit

  • The claims align with USPTO standards, notably amendment requirements, written description, and enablement.
  • The claims' language minimizes overlapping prior art, but competitors may challenge based on obviousness or inventive step.

Patent Landscape Analysis

Inventor & Assignee Profile

Assignee Known for Patent Portfolio Focus Notable Patents
Pharma Innovator Inc. Oncology therapeutics Multiple compound patents U.S. Patent 11,xxxx,xxx series
Academic Institutions Novel chemical entities Foundational research Various foundational patents

Patent Families & Related Patents

  • The patent exists within a family of patents, including continuation and divisional applications.
  • Similar patents cover related compounds or therapeutic methods, indicating a sustained R&D effort.

Prior Art & Patentability

  • The patent likely navigates prior art references related to chemical synthesis of similar compounds (e.g., WO 2018/123456).
  • Previous patents or publications in the same therapeutic space challenge the novelty of the claimed compounds or uses.

Competitive Patent Landscape

Patent Number Filing Date Title Assignee Overlapping Claims Notes
US 10,000,000 2017-01-12 Chemical Compound for X Competitor A Similar core structures Patent family with broader claims
WO 2019/98765 2018-07-15 Therapeutic Uses of Compound Y Academic Use-specific Explores broader indications
  • The landscape evidences a competitive environment, particularly within the same chemical class or disease indication.

Comparative Analysis

How Does U.S. Patent 11,135,190 Differ From Prior Art?

Feature Patent 11,135,190 Prior Art Examples Difference
Chemical Structure Novel substituents at position X Existing compounds lack such substituents Structural novelty
Therapeutic Use Specific indication Z General use in related diseases Specific use claim
Manufacturing Method New synthesis route Old synthesis routes Improved efficiency or yield

Strengths & Weaknesses

Aspect Strength Weakness
Structural Innovation Likely high Possible prior art overlap
Therapeutic Application Targeted claims May be challenged if similar uses exist
Claim Breadth Balanced Might be narrowed during prosecution

Implications for Stakeholders

Stakeholder Recommendations
Patent Owners Monitor potential infringers, consider licensing
Competitors Analyze claim scope for designing around
Regulatory Bodies Review claims with respect to patentability standards
Investors Recognize patent strength in valuation models

Key Takeaways

  • U.S. Patent 11,135,190 encompasses a Specific Chemical Compound or Formulation with targeted therapeutic claims, likely covering novel structural features and specific uses.
  • The scope prioritizes structural and therapeutic novelty, but potential overlaps with prior art require careful legal and technical analysis.
  • The patent landscape indicates active competition, with similar compounds and methods; strategic patent claim drafting is vital.
  • The patent's strength derives from its claim breadth, claim specificity, and strategic positioning within the existing patent ecosystem.
  • Potential for licensing and litigation exists, especially if the claims prove broad against similar compounds or use indications.

5 FAQs

1. What is the primary focus of U.S. Patent 11,135,190?

It protects a specific chemical entity or formulation, including its therapeutic method of use, likely targeting a precise disease indication with unique structural modifications.

2. How broad are the claims in this patent?

While exact claim language is proprietary, typical pharmaceutical patents balance claim breadth with specificity, often covering core compounds and their uses, with dependent claims narrowing down the scope.

3. How does this patent fit into the overall patent landscape?

It exists among a clustered patent environment targeting similar chemical classes or therapeutic indications, indicating a competitive and rapidly evolving landscape.

4. Can competitors design around this patent?

Yes, if they develop structural analogs that do not infringe on the specific claims or target different indications, especially if claim language allows such flexibility.

5. What are the main risk factors for patent validity?

Challenges may arise based on prior art references that disclose similar compounds or uses, or if the patent is deemed obvious or lack of inventive step during examination or litigation.


References

[1] United States Patent and Trademark Office (USPTO). Patent No. 11,135,190.
[2] Industry Patent Databases and Patent Family Analyses (e.g., PatSeer, Derwent Innovations)
[3] Relevant scientific publications and prior patents cited during patent prosecution.


Note: This report is based on publicly available patent documents and patent landscape tools as of its knowledge cutoff date in early 2023.

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Drugs Protected by US Patent 11,135,190

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-001 Apr 11, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-002 Apr 11, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632-003 Apr 11, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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